Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the publication of results from TARGET, a pivotal phase III study evaluating the efﬁcacy and safety of AVP-825 22mg in the January 2015 issue of Headache (Early access is now available). AVP-825 is an investigational drug-device combination product consisting of low-dose sumatriptan powder (22mg) delivered intranasally utilizing a novel Breath Powered™ delivery technology, for the acute treatment of migraine. A New Drug Application (NDA) for AVP-825 has been accepted and is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of November 26, 2014.
"Some studies indicate that nearly half of the 37 million Americans suffering from migraines are dissatisfied with their current treatment. We believe AVP-825 could provide a targeted, fast acting migraine treatment option by combining low-dose sumatriptan, the most widely used prescription migraine medication, with an innovative delivery method," said Joao Siffert, MD, chief medical officer for Avanir. "We are pleased to have the pivotal trial data published in a reputable medical journal and look forward to the upcoming FDA decision in November and to potentially being able to offer a new migraine treatment to patients in need."
The TARGET study data demonstrated relief of moderate or severe migraine headache as quickly as 15 minutes (19.4% AVP-825 vs. 14.4% placebo device) in subjects receiving AVP-825). A significantly greater proportion of AVP-825 patients reported headache relief at 30 minutes (41.7% vs. 26.9%, P=0.03) and at every time point up to two hours post-dose compared with those using the placebo device (67.6% vs. 45.2%, P=0.002). Relief was sustained through 24 and 48 hours in a greater proportion of patients who received AVP-825 vs. placebo. The treatment was well tolerated with a low incidence of adverse events (AEs), with the most common AEs being product taste (22%), nasal discomfort (13%), and rhinitis (3%); local AEs were transient and almost exclusively mild to moderate in severity.
Avanir Pharmaceuticals, Inc.